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Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury (TEMPLE)

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ClinicalTrials.gov Identifier: NCT02878850
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Miriam Treggiari, Oregon Health and Science University

August 3, 2016
August 25, 2016
March 22, 2018
April 10, 2017
December 2019   (Final data collection date for primary outcome measure)
Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores. [ Time Frame: 6 months after spinal cord injury ]
Change from baseline in long-term motor and sensory scores, comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge.
Same as current
Complete list of historical versions of study NCT02878850 on ClinicalTrials.gov Archive Site
  • Spinal Cord Independence Measure III score [ Time Frame: 6 months after spinal cord injury ]
    Spinal Cord Independence Measure III (Total Score, no units)
  • Pain scores on the International Spinal Cord Injury Basic Pain Data Set [ Time Frame: 6 months after spinal cord injury ]
    Pain scores on the International Spinal Cord Injury Basic Pain Data Set (Pain Interference Score; range 0-10)
  • Quality of Life [ Time Frame: 6 months after spinal cord injury ]
    Quality of Life (Life Satisfaction Score; range 0-10)
  • Cardiovascular Function [ Time Frame: 6 months after spinal cord injury ]
    Cardiovascular Function (Event occurrence)
Same as current
  • Number of respiratory complications [ Time Frame: 7 days after randomization or ICU discharge ]
    Number of respiratory complications (Event frequency)
  • Number of cardiac complications [ Time Frame: 7 days after randomization or ICU discharge ]
    Number of cardiac complications (Event frequency)
  • Sequential Multiple Organ Failure score (SOFA) [ Time Frame: 7 days after randomization or ICU discharge ]
    Sequential Multiple Organ Failure score (SOFA) (Total Score, no units)
Same as current
 
Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
The purpose of this study is to learn more about how participants heal from acute spinal cord injury.

In this study, the investigators will learn about the effect of targeted blood pressure management (TPM) on participants healing from acute spinal cord injury.

The investigators want to learn:

The effect of two types of TPM on long term motor and sensory outcomes. The effect of two types of TPM on long-term pain and functional independence outcomes.

How safe TPM is for participants.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Spinal Cord Injury
Other: Augmented Blood Pressure
Subjects will have their blood pressure kept in a higher range.
  • Experimental: Augmented Blood Pressure
    Subjects will have their blood pressure kept in a higher range.
    Intervention: Other: Augmented Blood Pressure
  • No Intervention: Conventional Blood Pressure
    Subjects will have their blood pressure kept in a normal range.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
Same as current
December 2020
December 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Acute traumatic SCI involving neurological levels as defined by the ASIA neurological examination between C0 and T8 (tetraplegia) and resulting in new onset neurological deficits consistent with an ASIA motor assessment of level A, B or C.
  2. Subject is 18 years of age or older.

Exclusion Criteria:

  1. Penetrating SCI injury.
  2. Isolated cauda equina syndrome or injury at bony level Th9 or below.
  3. Central cord syndrome, as determined by the primary admitting team.
  4. History of demyelinating disease or central nervous system autoimmune disorder.
  5. History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D).
  6. Acute, evolving or recent (30 days) myocardial infarction.
  7. Chronic renal failure requiring dialysis.
  8. Suspected or confirmed pregnancy.
  9. Severe terminal disease with life expectancy less than 6 months.
  10. Severe traumatic brain injury at presentation (GCS ≤8) with confirmation of injury on brain imaging.
  11. A condition that would preclude the performance of an accurate neurological exam due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation.
  12. Non-English or Non-Spanish Speaking.
  13. Refusal of consent.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Michael Kampp, BS, CCRP 503-494-5224 kamppm@ohsu.edu
Contact: Laura Sissons-Ross, AS 503-494-9545 sissonsr@ohsu.edu
United States
 
 
NCT02878850
TEMPLE - 001
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Miriam Treggiari, Oregon Health and Science University
Oregon Health and Science University
United States Department of Defense
Principal Investigator: Miriam Treggiari, MD, PhD, MPH Oregon Health and Science University
Oregon Health and Science University
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP